Eli Lilly faces FDA crackdown for manufacturing issues at plant handling COVID-19 antibody

Eli Lilly faces FDA crackdown for manufacturing issues at plant handling COVID-19 antibody

Source: 
Fierce Pharma
snippet: 


Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody.

The FDA cited Lilly's Branchburg, New Jersey facility on two counts of inadequate "control of computer systems," Lilly confirmed in an email. Those two findings included deleted data on the company's manufacturing processes and failed quality control control over audit paper trails, sources told Reuters.